Abdominal chemotherapy after surgery may improve mesothelioma outcomes
NCT ID NCT06057935
First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving chemotherapy directly into the abdomen (intraperitoneal) or into a vein (intravenous) after surgery and heated chemotherapy works better for people with malignant peritoneal mesothelioma. Participants must have had successful removal of visible cancer. The study compares how long the cancer stays under control with each approach.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pemetrexed and cisplatin (or carboplatin) given either into the abdomen or into a vein
- What this could lead to
- If it works, this could show that giving chemotherapy directly into the abdomen after surgery improves how long the cancer stays under control.
- What could go wrong
- This is a mid-stage trial with only 64 participants, so results may not apply to everyone. Chemotherapy has side effects, and the intraperitoneal route may cause more abdominal discomfort or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient age 18 years or older, both sexes. * Clinical diagnosis of MPM at enrolling institution. * Prior to randomization, intraoperative pathologic confirmation of epithelioid MPM at enrolling institution. * Complete or near-complete CRS achieved. * Patient must be planning to undergo complete cytoreduction of all peritoneal disease. * ECOG performance status ≤ 1. * Hematology: ANC ≥ 1,500/µl. * Platelets \> 75,000/µl. * Adequate renal function: creatinine \< 1.5× the upper limit of normal (ULN) or calculated creatinine clearance of ≥50 ml/min. * Adequate hepatic function: bilirubin \< 1.5 mg/dl (except in patients with Gilbert's syndrome, who must have total bilirubin \< 3.0 mg/dL). * Women of childbearing potential with a negative pregnancy test result (urine or blood) who agree to use an effective contraceptive method. Reliable contraception should be used from trial screening and must be continued throughout the study. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. * A man participating in this study must agree to utilize a reliable barrier form of contraception for the duration of the study * Signed and dated written informed consent to participate in this clinical trial must be obtained prior to any study procedure. Exclusion Criteria: * Subjects who have previously undergone intraperitoneal chemotherapy or systemic chemotherapy for peritoneal mesothelioma. * Subjects who have previously received platinum-containing chemotherapy regimens. * Subjects with preoperative or intraoperative biopsy consistent with sarcomatoid mesothelioma, well-differentiated papillary mesothelioma, or benign multicystic mesothelioma. * Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than three years, or indolent tumors for which observation over two years is a reasonable option. * High suspicion for extra-abdominal metastases. * Women who are pregnant or lactating. * Active coronary artery disease (defined as unstable angina or a positive cardiac stress test). Subjects with a history of coronary artery disease may be included if they have had a normal stress test within 60 days of enrollment or are determined by a cardiologist to be of acceptable perioperative risk. * Uncontrolled hypertension defined as \>140/90 and not cleared for surgery at the time of consent. * New York Heart Association (NYHA) Class II or higher congestive heart failure; restrictive or obstructive pulmonary disease that would limit study compliance or place the patient at unacceptable risk for participation in the study. * History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study. * Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or place them at an unacceptable risk for participation in the study. * Patients with known cisplatin, carboplatin, pemetrexed or mitomycin allergy. * Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon. * Any condition that would preclude the ability to deliver appropriate IP therapy. * Use of an oral medication, lacking a suitable non-oral substitute, that if held for up to ten days, would be felt an unacceptable risk by the investigator. * Life expectancy \< 12 weeks.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Allegheny Health Network (Data Collection Only)
RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activites)
RECRUITINGHarrison, New York, 10604, United States
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Rutgers University (Data Collection Only)
NOT_YET_RECRUITINGNew Brunswick, New Jersey, 08903, United States
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University of Chicago (Data Collection Only)
RECRUITINGChicago, Illinois, 60637, United States
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University of Michigan (Data Collection Only)
NOT_YET_RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of Nebraska (Data collection only)
NOT_YET_RECRUITINGOmaha, Nebraska, 68198-7680, United States
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Washington University (Data Collection Only)
NOT_YET_RECRUITINGSt Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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